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Short-term Clinical Feasibility of the Provox XtraHMEs for Pulmonary Rehabilitation After Total Laryngectomy

NCT00942903 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2010-10-22

Study results available
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Summary

This study is a short term feasibility study that aims to investigate patient satisfaction with and performance of new Provox Xtra HME in 20 laryngectomized patients. Aspects that are considered are for example performance for stoma occlusion, speaking, breathing, appearance, compliance, and short-term impact on pulmonary symptoms.

Conditions

  • Total Laryngectomy

Interventions

DEVICE

Provox Xtra HME

Heat and Moisture Exchanger for pulmonary Rehabilitation after total laryngectomy

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Atos Medical AB

    lead INDUSTRY

Principal Investigators

  • Frans JM Hilgers, MD · The Netherlands Cancer Institute

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00942903 on ClinicalTrials.gov